A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease

Official Title ICMJE

A Randomized Double Blind, Placebo-controlled Clinical Trial to Assess the Effects of Taspoglutide (RO5073031) on Cardiovascular Outcomes in Subjects With Inadequately Controlled Type 2 Diabetes and Established Cardiovascular Disease

Brief Summary

This randomized, double-blind, placebo-controlled parallel arm study will assess efficacy and safety and the effects of taspoglutide on cardiovascular events in patients with inadequately controlled type 2 diabetes mellitus and established cardiovascular disease. Patients will be randomized to receive either taspoglutide subcutaneously (sc) 10mg weekly for 4 weeks followed by 20mg sc weekly, or weekly sc placebo, in addition to background anti-hyperglycemic medication and standard of care treatment for cardiovascular disease. Anticipated time on study treatment is up to 2 years. Target sample size is 2000 patients.